Treatment apparatus for removing heat from subcutaneous lipid-rich cells and massaging tissue

ABSTRACT

A treatment device for removing heat from subcutaneous lipid-rich cells of a subject having an actuator that provides mechanical energy to the tissue. The mechanical energy provided may include a vibratory component that can range between low and ultra-high frequencies, and such energy may include various combinations of two or more frequencies tailored to produce the desired effect on the subcutaneous tissue. Disruption of adipose tissue cooled by an external treatment device may be enhanced by applying mechanical energy to cooled tissue. Furthermore, such mechanical energy may impart a vibratory effect, a massage effect, a pulsatile effect, or combinations thereof on the tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/815,454, filed Nov. 16, 2017, now pending, which is acontinuation of U.S. patent application Ser. No. 13/616,633, filed Sep.14, 2012, now abandoned, which is a continuation of U.S. patentapplication Ser. No. 11/750,953, filed on May 18, 2007, now abandoned.These applications are incorporated by reference in their entireties.

TECHNICAL FIELD

The present application relates generally to treatment devices, systems,and methods for removing heat from subcutaneous lipid-rich cells; moreparticularly, but not exclusively, several embodiments are directedtoward a treatment device including an actuator such as a vibrationdevice, a pneumatic device and/or a massage device and at least onetreatment unit to affect subcutaneous lipid-rich cells.

BACKGROUND

Excess body fat, or adipose tissue, can detract from personal appearanceand athletic performance. Excess adipose tissue may be present invarious locations of the body, including, for example, the thigh,buttocks, abdomen, knees, back, face, arms, and other areas. Moreover,excess adipose tissue is thought to magnify the unattractive appearanceof cellulite, which forms when subcutaneous fat protrudes into thedermis and creates dimples where the skin is attached to underlyingstructural fibrous strands. Cellulite and excessive amounts of adiposetissue are often considered to be unappealing. Moreover, significanthealth risks may be associated with higher amounts of excess body fat.An effective way of controlling or removing excess body fat therefore isneeded.

Liposuction is a method for selectively removing adipose tissue to“sculpt” a person's body. Liposuction typically is performed by plasticsurgeons or dermatologists using specialized surgical equipment thatinvasively removes subcutaneous adipose tissue via suction. One drawbackof liposuction is that it is a surgical procedure, and the recovery maybe painful and lengthy. Moreover, the procedure typically requires theinjection of tumescent anesthetics, which is often associated withtemporary bruising. Liposuction can also have serious and occasionallyeven fatal complications. In addition, the cost for liposuction isusually substantial. Other emerging techniques for removal ofsubcutaneous adipose tissue include mesotherapy, laser-assistedliposuction, and high intensity focused ultrasound.

Conventional non-invasive treatments for removing excess body fattypically include topical agents, weight-loss drugs, regular exercise,dieting, or a combination of these treatments. One drawback of thesetreatments is that they may not be effective or even possible undercertain circumstances. For example, when a person is physically injuredor ill, regular exercise may not be an option. Similarly, weight-lossdrugs or topical agents are not an option when they cause an allergic ornegative reaction. Furthermore, fat loss in selective areas of aperson's body cannot be achieved using general or systemic weight-lossmethods.

Other non-invasive treatment methods include applying heat to a zone ofsubcutaneous lipid-rich cells. U.S. Pat. No. 5,948,011 disclosesaltering subcutaneous body fat and/or collagen by heating thesubcutaneous fat layer with radiant energy while cooling the surface ofthe skin. The applied heat denatures fibrous septae made of collagentissue and may destroy fat cells below the skin, and the coolingprotects the epidermis from thermal damage. This method is less invasivethan liposuction, but it still may cause thermal damage to adjacenttissue, and can also be painful and unpredictable.

Additional methods of reducing subcutaneous adipocytes cool or otherwiseselectively remove or target them, as disclosed for example in U.S.Patent Publication Nos. 2003/0220674 and 2005/0251120, the entiredisclosures of which are incorporated herein. These publicationsdisclose, among other things, the concept of reducing the temperature ofsubcutaneous adipocytes to selectively affect them without damaging thecells in the epidermis and other surrounding tissue. Although themethods and devices disclosed in these publications are promising,several improvements for enhancing the implementation of these methodsand devices would be desirable.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, identical reference numbers identify similar elementsor acts. The sizes and relative positions of elements in the drawingsare not necessarily drawn to scale. For example, the shapes of variouselements and angles are not drawn to scale, and some of these elementsare arbitrarily enlarged and positioned to improve drawing legibility.Further, the particular shapes of the elements as drawn are not intendedto convey any information regarding the actual shape of the particularelements, and have been solely selected for ease of recognition in thedrawings.

FIG. 1 is an isometric view of a system for removing heat fromsubcutaneous lipid-rich cells in accordance with an embodiment of theinvention.

FIG. 2 is an isometric view of an actuator for use with a treatmentdevice in accordance with an embodiment of the invention.

FIG. 3 is an isometric view of the actuator of FIG. 2 coupled to a framesegment of a treatment device in accordance with an embodiment of theinvention.

FIG. 4 a is an isometric view of an actuator for use with a treatmentdevice in accordance with an embodiment of the invention. FIG. 4 b is anisometric and exploded view of the treatment device of FIG. 4 a.

FIG. 5 is a schematic view of an embodiment of the actuator of FIG. 4 inaccordance with an embodiment of the invention.

FIG. 6 is a schematic view of an embodiment of the actuator of FIG. 4 inaccordance with an alternative embodiment of the invention.

FIG. 7 is a schematic view of an embodiment of the actuator of FIG. 4 inaccordance with an alternative embodiment of the invention.

FIG. 8 is an isometric view of a treatment device for removing heat fromsubcutaneous lipid-rich cells in accordance with embodiments of theinvention.

FIG. 9 is an exploded isometric view of the treatment device of FIG. 8further illustrating additional components of the treatment device inaccordance with another embodiment of the invention.

FIG. 10 is an isometric top view of an alternative treatment device forremoving heat from subcutaneous lipid-rich cells in accordance with anembodiment of the invention.

FIG. 11 is an isometric bottom view of the alternative treatment deviceof FIG. 10 .

FIG. 12 is an isometric and exploded view of a treatment device forremoving heat from subcutaneous lipid-rich cells in accordance with afurther embodiment of the invention.

FIG. 13 is an isometric and exploded view of a vibrator disposed in thetreatment device for removing heat from subcutaneous lipid-rich cells inaccordance with yet another embodiment of the invention.

FIG. 14 is a block diagram showing computing system software modules forremoving heat from subcutaneous lipid-rich cells in accordance withanother embodiment of the invention.

DETAILED DESCRIPTION A. Overview

This document describes devices, systems, and methods for coolingsubcutaneous adipose tissue. The term “subcutaneous tissue” means tissuelying beneath the dermis and includes subcutaneous fat, or adiposetissue, which primarily is composed of lipid-rich cells, or adipocytes.Several of the details set forth below are provided to describe thefollowing embodiments and methods in a manner sufficient to enable aperson skilled in the relevant art to practice, make and use them.Several of the details and advantages described below, however, may notbe necessary to practice certain embodiments and methods of theinvention. Additionally, the invention may include other embodiments andmethods that are within the scope of the claims but are not described indetail.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment of the present invention. Thus, theoccurrences of the phrases “in one embodiment” or “in an embodiment” invarious places throughout this specification are not necessarily allreferring to the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. The headings provided herein are forconvenience only and do not limit or interpret the scope or meaning ofthe claimed invention.

The present invention is directed toward a treatment device for removingheat from subcutaneous lipid-rich cells of a subject and methods forusing such a device. The treatment device includes an actuator thatprovides mechanical energy to the tissue. The mechanical energy providedmay include a vibratory component that can range between low andultra-high frequencies, and such energy may include various combinationsof two or more frequencies tailored to produce the desired effect on thesubcutaneous tissue. According to an embodiment, for example, disruptionof adipose tissue cooled by an external treatment device may be enhancedby vibrating the cooled tissue. As applied to the tissue, then, suchvibration may impart a vibratory effect, a massage effect, a pulsatileeffect, combinations thereof, etc.

Several embodiments of treatment devices for removing heat fromsubcutaneous lipid-rich cells include at least one actuator and atreatment unit. The actuator may connect directly to the treatment unit,or the actuator may be affixed to a housing for the treatment unit.Alternatively, the treatment device may further include a flexiblesubstrate containing a treatment unit and the actuator is connected tothe flexible substrate. The actuator may provide mechanical energy tothe tissue. This may be done in a number of different ways; for example,varying mechanical energy, such as vibratory energy, may be impartedthrough the applicator. Alternatively, or additionally the tissue may bedirectly manipulated with varying pneumatic pressure. The actuator mayinclude a motor with an eccentric weight or other vibratory motors suchas hydraulic motors, electric motors, solenoids, other mechanicalmotors, or piezoelectric shakers to provide the energy to the treatmentsite. The treatment units may use a number of cooling technologiesincluding, for example, thermoelectric coolers, recirculating chilledfluid, vapor compression elements, or phase change cryogenic devices.One skilled in the art will recognize that there are a number of othercooling technologies and mechanical movement technologies that could beused such that the treatment units and mechanical devices need not belimited to those described herein.

Another embodiment of a treatment device may include one or moreactuators coupled to at least one of a plurality of interconnectedhinged or coupled segments; the hinged or coupled segments allow thetreatment device to conform to a body portion. The one or more actuatorsmay rigidly be affixed or releasably coupled to any portion of theinterconnected hinged or coupled segment. Alternatively, the one or moreactuators may be on or embedded in a flexible substrate which furthercontains the treatment units.

In yet another embodiment, a treatment device comprises one or moreactuators controllable to provide varying intensity, frequency, locationand/or duration of motion during treatment. The motion profile can, forexample, be configured to provide motion along a selected region of thetreatment device for a pre-selected or controlled time period.Alternatively, the motion profile may, for example, be configured toprovide periods of increased intensity. In other embodiments, the motionprofile may vary over time to provide a decreasing or an increasingintensity during treatment according to a predetermined pattern. Instill other embodiments, different actuators may simultaneously providedifferent types of motion or motion of varying intensity, frequency,location and/or duration between or among the actuators, or someactuators may be deactivated while others are activated in varyingpatterns throughout the course of treatment.

Additional embodiments disclosed below are directed toward methods ofaffecting lipid-rich cells by applying a treatment device and impartingmechanical energy to the target cells from one or more actuators. Theactuator may provide mechanical energy imparted to the tissue. Dependingon the frequency and amplitude of the mechanical energy, the mechanicalenergy may yield an effect such as a vibratory effect, a massage effect,a pulsatile effect, or any combination thereof that sends mechanicalenergy to the patient via or in connection with the treatment device.One embodiment of such a method includes arranging a treatment device ina desired configuration, cooling a heat exchanging surface of atreatment unit to a desired temperature, placing the cooled heatexchanging surface proximate to the subject's skin, activating anactuator that imparts mechanical energy to the tissue, and reducing thetemperature of a region such that lipid-rich cells in the region areaffected while non-lipid-rich cells in the region generally are notaffected. Alternatively, the actuator and the treatment units may be onand/or within a flexible substrate.

Further embodiments disclosed below are directed toward systems forefficiently removing heat from subcutaneous lipid-rich cells. Anembodiment of a system includes a treatment device having one or moreactuators coupled to a hinge, frame, substrate or other portion of thetreatment device. The actuator is configured to impart mechanical motionrelative to the skin of a patient, including positive and negativepressure; for example, the actuator may include a pneumatic feature,such as vacuum, for drawing and/or pressuring the subject's tissue awayfrom and/or towards, respectively, the treatment device. In anotherembodiment, the actuator may include a vibratory device for providingmechanical vibration transferred to the subject's tissue via thetreatment device. In yet another embodiment, the actuator may providemechanical energy to produce a massage effect, thus providing mechanicalmassage to the treated region. When placed proximate to a subject'sskin, the treatment device is capable of reducing a temperature of aregion such that lipid-rich cells in the region are affected whilenon-lipid-rich cells in the epidermis and/or dermis are not generallyaffected.

B. System for More Effectively Selectively Reducing Lipid-Rich Cells

FIG. 1 is an isometric view of an embodiment of a treatment system 100for removing heat from subcutaneous lipid-rich cells of a subject 101.The system 100 may include a treatment device 104 including an actuator105. The treatment device 104 may be placed, for example, at anabdominal area 102 of the subject 101 or another suitable area forcooling or removing heat from the subcutaneous lipid-rich cells of thesubject 101. Various embodiments of the treatment device 104 aredescribed in more detail below with reference to FIGS. 2-12 .

The system 100 may further include a treatment unit 106 and supply andreturn fluid lines 108 a-b between the treatment device 104 and thefluid source 107. The fluid source 107 can remove heat from a coolant toa heat sink and provide a chilled coolant to the treatment device 104via the fluid lines 108 a-b. Examples of the circulating coolant includewater, glycol, synthetic heat transfer fluid, oil, a refrigerant, and/orany other suitable heat-conducting fluid. The fluid lines 108 a-b may behoses or other conduits constructed from polyethylene, polyvinylchloride, polyurethane, and/or other materials that can accommodate theparticular circulating coolant. The treatment unit 106 may be arefrigeration unit, a cooling tower, a thermoelectric chiller, or anyother device capable of removing heat from a coolant. Alternatively, amunicipal water supply (i.e., tap water) may be used in place of thetreatment unit.

As explained in more detail below, the treatment device 104 includes atleast one actuator 105 and at least one treatment unit. The treatmentunit may be a Peltier-type thermoelectric element, and the treatmentdevice 104 may have a plurality of individually controlled treatmentunits to create a custom spatial cooling profile and/or a time-varyingcooling profile. The system 100 may further include a power supply 110and a processing unit 114 operatively coupled to the treatment device104 and the actuator 105. In one embodiment, the power supply 110provides a direct current voltage to a thermoelectric treatment device104 and/or the actuator 105 to remove heat from the subject 101. Theprocessing unit 114 may monitor process parameters via sensors (notshown) placed proximate to the treatment device 104 through power line116 to, among other things, adjust the heat removal rate based on theprocess parameters. The processing unit 114 may further monitor processparameters to adjust actuator 105 based on the process parameters. Theprocessing unit 114 may be in direct electrical communication withtreatment device 104 through electrical line 112 as shown in FIG. 1 ;alternatively, processing unit 114 may be connected to treatment device(and/or any number of other components of system 100 as discussed below)via a wireless or an optical communication link. Processing unit 114 maybe any processor, Programmable Logic Controller, Distributed ControlSystem, and the like. Note that power line 116 and line 112 are shown inFIG. 1 without any support structure. Alternatively, power line 116 andline 112 (and other lines including, but not limited to fluid lines 108a-b) may be bundled into or otherwise accompanied by a conduit or thelike to protect such lines, enhance user safety and ergonomic comfort,ensure unwanted motion (and thus potential inefficient removal of heatfrom subject 101) is minimized, and to provide an aesthetic appearanceto system 100. Examples of such a conduit include a flexible polymeric,fabric, or composite sheath, an adjustable arm, etc. Such a conduit maybe designed (via adjustable joints, etc.) to “set” the conduit in placefor the treatment of subject 101.

In another aspect, the processing unit 114 may be in electrical or othercommunication with an input device 118, an output device 120, and/or acontrol panel 122. The input device 118 may be a keyboard, a mouse, atouch screen, a push button, a switch, a potentiometer, any combinationthereof, and any other device or devices suitable for accepting userinput. The output device 120 may be include a display screen, a printer,a medium reader, an audio device, any combination thereof, and any otherdevice or devices suitable for providing user feedback. The controlpanel 122 may include visual indicator devices or controls (lights,numerical displays, etc.) and/or audio indicator devices or controls. Inalternative embodiments, the control panel 122 may be contained in,attached to, or integrated with the treatment device 104. In theembodiment shown in FIG. 1 , processing unit 114, power supply 110,control panel 122, treatment unit 106, input device 118, and outputdevice 120 are carried by a rack or cart 124 with wheels 126 forportability. In alternative embodiments, the processing unit 114 may becontained in, attached to, or integrated with the treatment device 104and/or the actuator 105. In yet another embodiment, the variouscomponents may be fixedly installed at a treatment site.

C. Actuator for Use with a Treatment Device

FIGS. 2, 3 and 4 are isometric views of embodiments of actuators 105 foruse with a treatment device 104 suitable for use in the system 100. Theactuator may provide mechanical energy to create a vibratory, massage,and/or pulsatile effect. The actuator may include one or more variousmotors, for example, motors with eccentric weight, or other vibratorymotors such as hydraulic motors, electric motors, pneumatic motors,solenoids, other mechanical motors, piezoelectric shakers, etc. toprovide vibratory energy to the treatment site. Further embodimentsinclude a plurality of actuators 105 for use in connection with a singletreatment device 104 in any desired combination. For example, aneccentric weight actuator may be associated with one treatment device104 while a pneumatic motor may be associated with another section ofthe same treatment device. This, for example, would give the operator oftreatment system 100 options for differential treatment of lipid richcells within a single region or among multiple regions of subject 101.The use of one or more actuators and actuator types in variouscombinations and configurations with treatment device 104 is possiblewith all the embodiments of the invention.

D. Treatment Device Having an Actuator Such as a Vibratory Device

FIG. 2 shows an actuator 105 including a motor 150 containing aneccentric weight 151 to create mechanical vibration, pulsing and/orcycling effect. Power is supplied to the motor 150 through power lines152. Alternatively, the motor 150 could be battery powered or couldinclude an electrical plug. Alternatively, vibration, pulsing and/orcycling can be induced by a mechanism using hydraulic, electric,electromechanical, solenoid, or mechanical devices as are known in theart. FIG. 3 shows the motor 150 of FIG. 2 affixed to a selected portionof the treatment device 104 as described further herein.

According to one embodiment, an actuator 105 is affixed by screws 154 orother mechanical fixation devices to a housing 156 of the treatmentdevice 104 to transmit mechanical energy through the treatment device104 to the tissue of a patient. Alternatively, the actuator 105 may bestrapped in place proximate to the treatment device 104 to transmitmechanical energy through the treatment device 104 of the tissue of thepatient. According to still further embodiments, the actuator 105 may beincorporated into the treatment device 104 to provide an integratedtreatment device with an activator for providing mechanical energy.

According to alternative embodiments, the treatment device 104 includesa plurality of links that are mechanically coupled with a plurality ofhinges and a single actuator to transfer mechanical vibratory energythrough adjacent links to the skin. Alternately, the actuator can beincorporated into more than one link, or a plurality of actuators may beused with a single treatment device.

In specific embodiments of the motor 150, the eccentric weight may be aweight machined out of brass; alternatively, the mass may be fabricatedfrom steel, aluminum, alloys thereof, high density polymeric materials,or any other relatively dense material. According to furtherembodiments, the motor used is a brushed DC motor; alternatively, anyelectric motor could be used, or any other means of rotating the mass asis known in the art.

The actuator 105 need not have a rotating eccentric weight; rather,other embodiments may have an electrical coil or the like to create avarying or pulsing energy. The electrical coil, for example, may includea solenoid, a vibrating armature or a voice coil. According to anembodiment using a solenoid, a coil is energized to create a magneticfield that moves a steel or iron armature. The armature may be attachedto a mass and can be driven into a hard stop to produce a pulse. If thehard stop is mechanically coupled to the device applied to the skin,this energy will be transferred into the tissue. This method ofimparting mechanical energy to lipid-rich cells so to create a massageor massage-like effect is suited, but not necessarily limited, to lowerfrequencies and higher impulse energies.

A specific embodiment of a vibrating armature or voice coil has a coildriven by an alternating current to move or oscillate the armature backand forth. The inertia of this motion may be transferred through thelink into the tissue to provide an actuator for enhancing the vibratoryeffect on the lipid-rich cells.

According to still further embodiments, the mechanical force may createa massage massage-like effect using a water hammer. Water, or any of anumber of other heat transfer fluids suitable for cooling thethermoelectric coolers, can have significant mass, and when flowingthrough tubing, these fluids can commensurately have significantmomentum. By quickly halting the flow of such a fluid, such as, e.g., byplacing a solenoid valve in the fluid line and closing the flow path, aproperly designed system transfers the momentum of the fluid to thetreatment device 104 and into the tissue. According to aspects of thisembodiment, such a water hammer or similar momentum-transferringarrangement is suited to low frequencies. Further, such an arrangementmay reduce the heat transfer rate, which may be desirable for certainapplications.

In operation, the motor 150 shown in FIG. 2 rotates an eccentric weightto provide mechanical energy. The motor is rigidly attached to thetreatment device 104, for example, to a housing 156 of the treatmentdevice 104 as shown in FIG. 3 . Mechanical energy creating a pulsing,cycling, or oscillation effect is applied by the centripetal forcegenerated as the eccentric weight rotates, creating a varying or pulsingmechanical energy. This energy is transferred through the treatmentdevice 104 to the patient's skin and underlying tissue. The frequency ofthe vibration can be increased by increasing the rotational rate of theweight. A higher frequency also increases the applied force of thevibration. According to one embodiment, the frequency of massage (orvibration) is in the range of about 0.1 Hz to about 50 MHz, and morepreferably in the range of between about 200 Hz and about 400 Hz,according to alternative embodiments; the frequency of massage (orvibration) can be higher or lower. The motor 150 may further includepassive or active damping materials (not shown). The force appliedduring each rotation of the weight may be increased, for example, byincreasing the mass of the weight or increasing the distance between thecenter of gravity of the weight and its axis of rotation. Similarly,decreasing the mass of the weight or decreasing the distance between thecenter of gravity of the weight and its axis of rotation may, forexample, decrease the force applied during each rotation of the weight.The appropriate force is dependent on the mass of the housing 156 orother component of the treatment device 104 to which the motor 150 isapplied. According to embodiments, a more massive housing assemblyrequires a more massive eccentric weight so that the vibratory force istransferred through the housing 156 into the tissue to which thetreatment device 104 is applied.

The illustrated embodiment of the actuator as shown in FIG. 2 can allowa compact and relatively low power actuator 105 to be coupled to one ormore of the link assemblies of a treatment device 104. By coupling theactuator 105 to the treatment device 104, mechanical energy may beapplied at any time in the cooling or heating process withoutnecessarily removing the applicator. Alternatively, the applicator maybe removed and an actuator such as a commercial massage device may beapplied to the tissue or the tissue may be manually massaged.

In addition, the illustrated embodiment may provide acceleration andenhancement of the ischemic reperfusion damage to adipose tissue throughmechanical massage or vibration. Further, the illustrated embodiment ofthe actuator and the treatment device combine to provide an enhancedability to disrupt crystallized adipose cells and further affectlipid-rich cells.

E. Treatment Device Having an Actuator Such as a Vacuum Device

FIGS. 4 a and 4 b show a vacuum device 160 suitable for use with atreatment device for applying a vacuum to the subject's tissue before,during and/or after cooling. As discussed with reference to FIG. 3 , theactuator 105, shown as a vacuum device 160 in this embodiment, mayinclude a vacuum cup and treatment units 408 a, 408 b affixed to thevacuum device 160. The vacuum device 160 may provide mechanical energyto a treatment region. Imparting mechanical vibratory energy to thepatient's tissue by repeatedly applying and releasing a vacuum to thesubject's tissue, for instance, creates a massage action. Alternatively,massage devices as are known in the art may be used to enhance thedesired effect on lipid-rich cells. FIGS. 5-7 illustrate schematicdiagrams of embodiments of the vacuum device 160.

As described herein, techniques for incorporating massage into atreatment device 105 may include using a pressure differential to drawthe skin against a thermally controlled plate or plates. In an actuatorsuch as the vacuum device 160 shown in FIGS. 4 a and 4 b , a vacuum line162 can be connected to the vacuum device 160. In operation, air isevacuated from a chamber in the vacuum device 160 create a pressuredifferential which draws a fold of the subject's skin and subcutaneoustissue up inside a reservoir 430 of the vacuum device 160 and againstthe treatment units 408 a, 408 b.

The vacuum device 160 defines the reservoir 430 for receiving tissue ofa subject during treatment. The vacuum device 160 may further includetreatment units 408 a, 408 b positioned at opposite sides of the vacuumdevice 160. Alternatively, the treatment units 408 a, 408 b may beadjacent one another. Further, vacuum device 160 may comprise a vacuumcup and a single treatment unit or more than two treatment units. Asshown in the example of FIG. 4 b , one or both of the treatment units408 a, 408 b may include a heat exchanging interface 420 fortransferring heat to/from the subject 101. A cryoprotectant or couplingagent (not shown) may be applied to the heat exchanging interface 420 toprevent ice from forming thereon when the temperature is reduced to atemperature around or below the freezing point of water (0° C.). In oneembodiment, the heat exchanging interface 420 is generally planar, butin other embodiments, the heat exchanging interface 420 is non-planar(e.g., curved, faceted, etc.) The interface 420 may be constructed fromany suitable material with a thermal conductivity greater than 0.05Watts/Meter K, and in many embodiments, the thermal conductivity is morethan 0.1 Watts/Meter K. Examples of suitable materials include aluminum,other metals, metal alloys, graphite, ceramics, some polymericmaterials, composites, or fluids contained in a flexible membrane.Portions of the heat exchanging element 420 may be an insulatingmaterial with a thermal conductivity less than about 0.05 Watts/Meter K.

The heat exchanging interface 420 may also include at least one sensingelement (not shown) proximate to the heat exchanging interface 420. Thesensing element, for example, may be generally flush with the heatexchanging interface 420. Alternatively, it may be recessed or protrudefrom the surface. The sensing element may include a temperature sensor,a pressure sensor, a transmissivity sensor, a bio-resistance sensor, anultrasound sensor, an optical sensor, an infrared sensor, a sensor formeasuring blood flow, or any other desired sensor. In one embodiment,the sensing element may be a temperature sensor configured to measurethe temperature of the heat exchanging interface 420 and/or thetemperature of the skin of the subject. For example, the temperaturesensor may be configured as a probe or as a needle that penetrates theskin during measurement. Examples of suitable temperature sensorsinclude thermocouples, resistance temperature devices, thermistors(e.g., neutron-transmutation-doped germanium thermistors), and infraredradiation temperature sensors. In another embodiment, the sensingelement may be an ultrasound sensor configured to measure the thicknessof a fat layer in the subject or crystallization of subcutaneous fat inthe treatment region of a subject. In yet another embodiment, thesensing element may be an optical or infrared sensor configured tomonitor an image of the treatment region to detect, for example,epidermal physiological reactions to the treatment. In yet anotherembodiment, the sensing element may be a device to measure blood flow.The sensing element may be in electrical communication with theprocessing unit 114 via, for example, a direct wired connection, anetworked connection, and/or a wireless connection.

The vacuum device 160 may further include a mounting element 406 thatcouples the treatment units 408 a, 408 b to the vacuum device 160. Themounting element 406, for example, may be a bracket, frame or othersuitable fixture. The treatment units 408 a, 408 b may include a heatsink 402 with a cover 401, and a thermoelectric cooler 404 disposedbetween the heat sink 402 and the heat exchanging interface 420. Thethermoelectric cooler 404 may be a single Peltier-type element or aplurality of Peltier-type elements. One suitable thermoelectric cooleris a Peltier-type heat exchanging element (model #CP-2895) produced byTE Technology, Inc. in Traverse City, Mich.

In the illustrated embodiment, the heat sink 402 includes a serpentineshaped fluid conduit at least partially embedded in the heat sink 402.In the illustrated embodiment, the heat sink includes fluid ports 410 a,410 b that may be coupled to a circulating fluid source (not shown) viathe fluid lines 108 a-b. In other embodiments, the heat sink 402 mayinclude a plate-type heat exchange, a tube and a shell heat exchanger,and/or other types of heat exchanging devices.

Vacuum pressure may be supplied by any pump (e.g., pump 407 shown inFIG. 4B) capable of creating a pressure differential. Air pressure caneither be controlled with a regulator between the vacuum source and theapplicator, or pressure may be reduced up to the maximum capacity of thepump. For example, systems incorporating a regulator immediatelydownstream of the pump are designed to eliminate the regulator by sizinga pump with an appropriate maximum pressure capacity. According to oneembodiment, approximately 5 inches Hg of vacuum is applied; inalternative embodiments, higher or lower vacuum levels are applied. Inthis embodiment, if the vacuum level is too low, the tissue will not bedrawn adequately (or at all) inside reservoir 430 of the vacuum device160; if the vacuum level is too high, undesirable discomfort to thepatient and/or tissue damage could occur.

By alternating between two different vacuum levels inside the vacuumdevice 160, the force applied to the tissue will concomitantly increaseand decrease, having the effect of a massaging action on the tissue.This may be accomplished, for instance, by ensuring the minimum vacuumlevel is high enough to keep the tissue drawn into the vacuum device160, and have the tissue drawn further inside vacuum device 160 when thehigher vacuum level is applied. If the tissue is drawn inside theapplicator to the largest extent possible, friction between the walls ofthe applicator and the tissue may cause the tissue to maintain itsoverall position or assist the tissue in maintaining such a position.The change in vacuum pressure level at a desired frequency pulses thetissue, moving the area of tissue exposed to the vacuum to alternatingpositions within vacuum device 160. This is possible in part becauseinitially, a higher pressure differential is required to draw the tissuepast the sealing surface of the reservoir 430 and up inside thereservoir 430; however, once the tissue has been drawn into place, theforce (and therefore the vacuum level) required to hold the tissue inplace is lower. In this embodiment, the lower vacuum level (nearer toambient pressure) may be very low, potentially as low as 1 inch of Hg orlower. The higher pulsing pressure can be 2 inches of mercury vacuum orhigher. In operations, increasing the difference between the two vacuumlevels increases the massage force. Further, increasing the cycle ratebetween the two pressures increases the massage frequency. Accordingly,the tissue can be pulsed in the range of approximately 0.1 Hz or lowerand 10 Hz or higher. It is also possible to select the two vacuum levels(and possibly other parameters such as frequency, etc.) sufficient todraw the tissue into the vacuum device reservoir 430 and to impart amassage or pulsatile effect to the tissue while keeping the tissueposition relatively constant inside reservoir 430 as alternating levelsof vacuum are applied. This may be accomplished, for example, bydecreasing the relative difference between vacuum levels applied to thetissue but by keeping the lower vacuum level high enough to keep thetissue drawn into the reservoir 430 of vacuum device 160 duringtreatment.

One method of creating this pneumatic massaging action is with avariable speed pump. Using pressure feedback to control the pump speed,the pump may electronically be controlled between two different vacuumlevels. According to this embodiment, there is a mechanical lag in thetime it takes the pump to change speeds, therefore, this embodiment maynot be capable of pulsing at a frequency as high as some of the otherembodiments described herein. According to yet another embodiment, alarge piston is coupled to the treatment device 104; the piston isdriven back and forth, either pneumatically or mechanically, to create apressure wave in the system.

In an alternate embodiment shown in FIG. 5 , one pump, two regulatorsand a 3-way valve may be used to switch between the two regulators.Alternative embodiments may be created, for example, by removing thehigher vacuum pressure regulator or moving the 3-way valve in front ofthe regulators. In yet another embodiment, the 3-way valve could bereplaced with two 2-position valves. According to this embodiment, thevalves are solenoid valves, however, according to further embodiments,pneumatically controlled valves could be used.

Alternately, as shown in FIG. 6 , two pumps and two regulators may beused. According to aspects of this embodiment, the dynamic response ofthe system is improved. Further, this embodiment may optionally becoupled with pneumatic cylinders to improve the pneumatic response ofthe system and provide for higher massage frequencies. According tostill further embodiments, the regulators may be removed to allow thepumps to operate to their maximum pressure capacities. Other embodimentsinclude systems in which the regulators take on different positionsrelative to the pumps or those in which different types of regulatorsare used.

As shown in FIG. 7 , a valve and a backpressure regulator may beinstalled in the system. In operation, when the valve is opened, thepressure in the system reduces to the pressure set by the regulator.According to further embodiments, the regulator may be removed and thevalve may be controlled by the processing unit 114. Further, the valvemay be opened and air can be vented through an orifice (not shown) tolimit the flow rate. The valve could be closed when the lower pressurelimit is reached as measured by the pressure transducer, and the systemwould be returned to the higher vacuum pressure by the pump. Oneadvantage of this embodiment is that the pressure relief would occurvery quickly, thus possibly affording higher massage frequencies, amongother advantages.

The illustrated embodiments of the actuator 105 combined with thetreatment device 104 can enhance disruption of adipose tissue cooled byan external skin treatment device. Further, the illustrated embodimentmay reduce treatment time, reduce discomfort to the patient and increaseefficacy of treatment. For example, in an alternative embodiment, thevacuum device 160 may be employed without any vibratory, pulsing, ormassage effect on the tissue drawn therein; rather, the vacuum maystatically draw tissue into the reservoir 430 of the vacuum device 160,and hold the tissue in the reservoir 430 while cooling through a portionof or up to the entire duration of the treatment time, and releasing itonly when the cooling treatment protocol is completed. Without beingbound by theory, it is believed that while drawn into the vacuum devicereservoir 430, the relative physical isolation of the targetsubcutaneous adipose tissue beneath the epidermis from the thermal massof tissue normally below such tissue that is not drawn into reservoir430 (e.g., underlying vasculature, muscles, etc.) and the reduction inblood circulation through the tissue drawn into reservoir 430 allow fora more efficient temperature reduction of lipid-rich cells such that thelipid-rich cells are substantially affected while non-lipid-rich cellsin the epidermis are not substantially affected. This may have theadvantage of increasing the efficacy of treatment and/or reducingtreatment times.

F. Treatment Device Having a Plurality of Treatment Units

FIG. 8 is an isometric view of a treatment device 800 in accordance witha specific embodiment of a treatment device 800 for use with an actuator105. In this embodiment, the treatment device 800 includes a controlsystem housing 202 and treatment unit housings 204 a-g. The actuator 105may be coupled with, affixed to or contained within the control systemhousing 202 or the treatment unit housings 204 a-g. The control systemhousing 202 includes a sleeve 308 (FIG. 9 ) that may slide into collar310 and/or may mechanically attach to the treatment unit housings. Theactuator 105 may further couple with, affix to, or be contained within,or encircle the sleeve 308.

The treatment unit housings 204 a-g are connected to the heat exchangingelements (not shown) by attachment device 206. The attachment device maybe any mechanical attachment device such as a screw or pin as is knownin the art. The plurality of treatment unit housings 204 a-g may havemany similar features. As such, the features of the first treatment unithousing 204 a are described below with reference symbols followed by an“a,” corresponding features of the second treatment unit housing 204 bare shown and noted by the same reference symbol followed by a “b,” andso forth. The treatment unit housing 204 a may be constructed frompolymeric materials, metals, ceramics, woods, and/or other suitablematerials. The example of the treatment unit housing 204 a shown in FIG.2A-C is generally rectangular, but it can have any other desired shape.

The control system housing 202 may house that actuator 105 and/or aprocessing unit for controlling the treatment device 800 and/or fluidlines 108 a-b and/or electrical power and communication lines. Thecontrol system housing 202 includes a harness port 210 for electricaland supply fluid lines (not shown for purposes of clarity). The controlsystem housing 202 may further be configured to serve as a handle for auser of the treatment device 800. Alternatively, a plurality ofactuators (not shown) may be contained on any one of the treatment unithousing segments 204 a-g.

As shown in FIG. 8 , the treatment device 800 may further include ateach end of the treatment device 800 retention devices 208 a and 208 bcoupled to a frame 304. According to embodiments of the invention, theactuator 105 may further be coupled to the retention devices 208 a and208 b. The retention devices 208 a and 208 b are rotatably connected tothe frame by retention device coupling elements 212 a-b. The retentiondevice coupling elements 212 a-b, for example, can be a pin, a balljoint, a bearing, or other type of rotatable joints.

The treatment device 104 includes a frame 304 having a plurality ofrotatably connected segments 305 a-g. The rotatably connected segments305 a-g are connected by hinges 306 a-f, and, according to oneembodiment, the actuator 105 is attached to at least one of the hinges306 a-f. Alternatively, the rotatably connected segments 305 a-g of theframe 304 could be connected by a connection that allows rotation, suchas a pin, a living hinge or a flexible substrate such as webbing orfabric or the like. According to one aspect of the invention, the linksor hinges are made of plastic to insulate the treatment units from eachother.

FIG. 9 is an exploded isometric view of the treatment device of FIG. 8in accordance with one example of the invention for use in the system100 as further described in U.S. patent application Ser. No. 11/528,225,which is herein incorporated in its entirety by reference. This furtherexploded view is substantially similar to previously described examples,and common acts and structures are identified by the same referencenumbers. Only significant differences in operation and structure aredescribed below. As can be appreciated by one skilled in the art, theactuator may be coupled to the treatment device at a variety of points;for example, the actuator may be contained within the housing, coupledto an outer surface of the housing, affixed to the frame at the hinge oralong a segment, coupled to the treatment units, or coupled by anycombination of connection points by any appropriate connection means asare known in the art.

FIG. 10 is an isometric view of a plurality of thermoelectric coolerscontained in a matrix design according to yet another treatment devicethat may be used with an actuator. As shown in FIGS. 10 and 11 , thetreatment device 810 includes a treatment unit 804 configured in aplanar matrix 824 of thermoelectric coolers 826. According to oneembodiment, the actuator 105 may be integral to the planar matrix 824,may attach to a portion of the planar matrix 824 or may be releasablycoupled to the planar matrix 824. The treatment device 810 may furtherinclude a band 812 for retaining the treatment unit 804 in place duringuse and the actuator can be contained within or coupled to the band 812.The treatment device may further include a handle 814, a wiring harness818 and a flap 816 for releasably securing the band 812 to the treatmentunit 804. The actuator 105 may be contained within or coupled to thehandle 814, wiring harness 818 and/or flap 816.

G. Operation of the Treatment Device

Without being bound by theory, it is believed that in operationeffective cooling from the treatment device, which cools throughconduction, depends on a number of factors. Exemplary factors thatimpact heat removal from the skin area and related tissue are thesurface area of the treatment unit, the temperature of the interfacemember and the mechanical energy delivered to the tissue.

According to illustrated embodiments, the actuator 105 and the treatmentdevice 104 combine to enhance disruption of cooled adipose tissue.Further, the illustrated embodiments may provide reduced treatment time,reduced discomfort to the patient and increased efficacy of treatment.

The illustrated embodiments can provide the treatment device 104 and theactuator 105 which reduce subcutaneous lipid-rich cells generallywithout collateral damage to non-lipid-rich cells in the treatmentregion. In general, lipid-rich cells can be affected at low temperaturesthat do not affect non-lipid-rich cells. As a result, lipid-rich cells,such as subcutaneous adipose tissue, can be affected while other cellsin the same region are generally not damaged even though thenon-lipid-rich cells at the surface are subject to even lowertemperatures. The mechanical energy provided by the actuator furtherenhances the affect on lipid-rich cells by disrupting the affectedlipid-rich cells.

In alternative embodiments, a cryoprotectant is used with the treatmentdevice to, among other advantages, prevent freezing of the tissue duringtreatment as is described in U.S. patent application Ser. No.11/741,271, filed Apr. 27, 2007, and entitled “Cryoprotectant for usewith a Treatment Device for Improved Cooling of Subcutaneous Lipid-RichCells,” herein incorporated in its entirety by reference.

H. Spatially Controlled Treatment Unit Profile

According to aspects of the invention, a spatially controlled profilecan provide more efficient cooling to the treatment region. Theplurality of actuators and/or thermoelectric coolers allows thetreatment device to accommodate spatial cooling. For example, actuatorsmay be contained at the perimeter of the treatment device to provideadditional mechanical energy (via increased amplitude, or intensity, orvia a longer duration, or any combination thereof) than mechanicalenergy provided by actuators contained at the interior of the treatmentdevice because of different boundary conditions in the different areasof the treatment zone. Alternatively, individual actuators, or groups ofindividual actuators, may be actuated at varying times or with varyingfrequency in any combination to provide a varying spatial profile ofimparted mechanical energy over the treatment region.

According to aspects of the invention, the device can accommodatespatially controlled treatment profiles which may provide at least thefollowing advantages: (1) increased efficiency; (2) decreased powerconsumption with comparable efficacy; (3) increased patient comfort; or(4) decreased treatment time. For example, according to aspects of theinvention, the plurality of actuators will allow adjustment foranatomical differences between patients by selectively enabling ordisabling portions of the apparatus based on anatomical differences ofthe patient. This selective enablement may be accomplished by varyingboth the mechanical actuation mechanism and/or the cooling profile inany number of ways.

For instance, another alternative involves the implementation of aparticular pattern of controlled cooling which may be customized tomatch an individual patient's pattern of cellulite, or subcutaneous fat,thus increasing the efficacy of the treatment and allowing the“sculpting” or contouring of the patient's tissue to achieve a desiredaesthetic or other effect. Similarly, treatment regions requiring ahigher intensity of treatment may be pre-identified by ultrasound orother devices. The device can then be spatially controlled to providehigher intensity treatment to those pre-identified areas. Furtheradvantages include increased patient comfort and safety by allowingspatial control of cooling to accommodate special features of aparticular patient's anatomy (e.g., lumps such as lipomas, blemishes orscars, areas having excess hair, areas containing implants or jewelry,or areas of heightened sensitivity such as nipples or wounds).

A further advantage of spatial control of the device includes utilizingonly a subset of the actuators in order to treat only the regionrequiring treatment. It is advantageous to use one device that canaccommodate small and large treatment regions without over treating(e.g. a large device that cannot be spatially controlled) or having tomove the device multiple times thus extending the treatment time (e.g. atreatment device smaller than the treatment region). Thus, according toaspects of the invention, a selected region of actuators can becontrolled to provide mechanical energy to select regions.Alternatively, a first actuator of the treatment device can be turnedoff while a second actuator of the treatment device is activated, suchthat only a selected region of the subject is treated with mechanicalenergy, thus limiting the treatment region. Other advantageous spatiallycontrolled patterns include treating areas within the treatment regionmore intensely, conserving power by alternating actuators, increasingmechanical energy at a perimeter in order to provide a uniform energydistribution across the treatment area, and a combination of thesespatially controlled patterns in order to increase treatment efficacy,reduce treatment time, decrease power consumption and provide forpatient comfort and safety.

It is expressly understood that embodiments of the inventionspecifically contemplate utilizing, via spatial control or even arandomly selected profile, varying combinations of actuation to impartmechanical energy as described herein with applying treatment devices toaffect the lipid-rich cells in any number of ways (e.g., varyingfrequency, intensity (amplitude), duration, start and stop times,temperature, etc.), applying mechanical energy alone without cooling,applying cooling alone without mechanical energy, utilizing reheating toaccelerate damage to lipid-rich cells, to achieve the desired effect.

I. Method of Applying Treatment Devices

In one mode of operation, the actuator is coupled to a treatment device.The treatment device may be configured to be a handheld device such asthe device disclosed in U.S. patent application Ser. No. 11/359,092,entitled “Treatment device For Removing Heat From SubcutaneousLipid-Rich Cells”, filed on Feb. 22, 2006, herein incorporated in itsentirety by reference. The treatment device may be configured to be aplurality of treatment devices contained in a flexible substrate or in arotatable housing such as the device disclosed in U.S. patentapplication Ser. No. 11/528,225, entitled “Cooling Devices Having aPlurality of Controllable Treatment units to Provide a PredeterminedCooling Profile”, filed on Sep. 26, 2006, herein incorporated in itsentirety by reference.

Applying the treatment device with pressure to the subject's skin orpressing against the skin can be advantageous to achieve efficientcooling. In general, the subject 101 has a body temperature of about 37°C., and the blood circulation is one mechanism for maintaining aconstant body temperature. As a result, blood flow through the dermisand subcutaneous layer of the region to be treated may be viewed as aheat source that counteracts the cooling of the subdermal fat. As such,cooling the tissue of interest requires not only removing the heat fromsuch tissue but also that of the blood circulating through this tissue.Thus, temporarily reducing or eliminating blood flow through thetreatment region, by means such as, e.g., applying the treatment devicewith pressure, can improve the efficiency of tissue cooling and avoidexcessive heat loss through the dermis and epidermis.

By cooling the subcutaneous tissue to a temperature lower than 37° C.,subcutaneous lipid-rich cells can be selectively affected. In general,the epidermis and dermis of the subject 101 have lower amounts ofunsaturated fatty acids compared to the underlying lipid-rich cellsforming the subcutaneous tissues. Because non-lipid-rich cells usuallycan withstand colder temperatures better than lipid-rich cells, thesubcutaneous lipid-rich cells can be selectively affected whilemaintaining the non-lipid-rich cells in the dermis and epidermis. Anexemplary range for the treatment unit 302 a-g can be from about −20° C.to about 20° C., preferably from about −20° C. to about 10° C., morepreferably from about −15° C. to about 5° C., more preferably from about−10° C. to about 0° C.

The lipid-rich cells can be affected by disrupting, shrinking,disabling, destroying, removing, killing, or otherwise being altered.Without being bound by theory, selectively affecting lipid-rich cells isbelieved to result from localized crystallization of highly saturatedfatty acids at temperatures that do not induce crystallization innon-lipid-rich cells. The crystals can rupture the bi-layer membrane oflipid-rich cells to selectively necrose these cells. Thus, damage ofnon-lipid-rich cells, such as dermal cells, can be avoided attemperatures that induce crystal formation in lipid-rich cells. Coolingis also believed to induce lipolysis (e.g., fat metabolism) oflipid-rich cells to further enhance the reduction in subcutaneouslipid-rich cells. Lipolysis may be enhanced by local cold exposure,inducing stimulation of the sympathetic nervous system.

Additional Embodiments of Treatment Device

FIG. 12 is an isometric and exploded view of a treatment device 104 inaccordance with another embodiment of the invention. The treatmentdevice 104 may include a housing 300, a cooling assembly 308 at leastpartially disposed in the housing 300, and retention devices 318configured for fastening the cooling assembly 308 to the housing 300.The treatment device 104 may also include a vibration member disposed inthe housing 300, as described in more detail below with reference toFIG. 13 .

The cooling assembly 308 may include a heat sink 312, a thermallyconductive interface member 309, and a thermoelectric cooler 314disposed between the heat sink 312 and the interface member 309. Thethermoelectric cooler 314 may be connected to an external power supply(not shown) via connection terminals 316. In the illustrated embodiment,the heat sink 312 includes a U-shaped fluid conduit 310 at leastpartially embedded in a thermally conductive portion 313 of the heatsink 312. The fluid conduit 310 includes fluid ports 138 a-b that may becoupled to a circulating fluid source (not shown) via the fluid lines108 a-b. In other embodiments, the heat sink 312 may include aplate-type heat exchanger, a tube and shell heat exchanger, and/or othertypes of heat exchanging device. The interface member 309 may include aplate constructed from a metal, a metal alloy, and/or other types ofthermally conductive material. The thermoelectric cooler 314 may be asingle Peltier-type element or an array of Peltier-type elements. Onesuitable thermoelectric cooler is a Peltier-type heat exchanging element(model #CP-2895) produced by TE Technology, Inc. in Traverse City, Mich.

Individual retention devices 318 may include a plate 330 and a pluralityof fasteners 306 extending through a plurality of apertures 332 (two areshown for illustrative purposes) of the plate 330. In the illustratedembodiment, the fasteners 306 are screws that may be received by thehousing 300. In other embodiments, the fasteners 306 may include bolts,clamps, clips, nails, pins, rings, rivets, straps, and/or other suitablefasteners. During assembly, the cooling assembly 308 is first at leastpartially disposed in the internal space 303 of the housing 300. Then,the retention devices 318 are positioned proximate to the coolingassembly 308, and the fasteners 306 are extended through the apertures332 of the plate 330 to engage the housing 300. The fasteners 306, theplates 330, and the housing 300 cooperate to hold the cooling assembly308 together.

By applying power to the thermoelectric cooler 314, heat may beeffectively removed from the skin of the subject to a circulating fluidin the fluid conduit 310. For example, applying a current to thethermoelectric cooler 314 may achieve a temperature generally below 37°C. on the first side 315 a of the thermoelectric cooler 314 to removeheat from the subject via the interface member 309. The thermoelectriccooler 314 transfers the heat from the first side 315 a to the secondside 315 b. The heat is then transferred to the circulating fluid in thefluid conduit 310.

FIG. 13 is an isometric and exploded view of a vibrator 322 disposed inthe treatment device 104 of FIG. 12 . The vibrator 322 may include aframe 324, a motor 325 carried by the frame 324, a rotating member 328operatively coupled to the motor 325, and a plurality of fasteners 326(e.g., screws) for fixedly attaching the frame 324 to the housing 300.In the illustrated embodiment, the motor 325 has an output shaft (notshown) generally centered about a body axis 327 of the motor 325. Onesuitable motor is a direct current motor (model #Pittman 8322S008-R1)manufactured by Ametek, Inc., of Harleysville, Pa. The rotating member328 has a generally cylindrical shape and is off-centered from the bodyaxis 327. In other embodiments, the motor 325 may have an off-centeredshaft that is operatively coupled to the rotating member 328.

In operation, applying electricity to the motor 325 may cause therotating member 328 to rotate around the body axis 327 of the motor 325.The off-centered rotating member 328 causes the vibrator 322 to beoff-balanced about the body axis 327, and vibration in the frame 324 andthe housing 300 may result.

J. Computing System Software Modules

FIG. 14 is a functional diagram showing exemplary software modules 940suitable for use in the processing unit 114. Each component may be acomputer program, procedure, or process written as source code in aconventional programming language, such as the C++ programming language,and can be presented for execution by the CPU of processor 942. Thevarious implementations of the source code and object and byte codes canbe stored on a computer-readable storage medium or embodied on atransmission medium in a carrier wave. The modules of processor 942 caninclude an input module 944, a database module 946, a process module948, an output module 950, and, optionally, a display module 951. Inanother embodiment, the software modules 940 can be presented forexecution by the CPU of a network server in a distributed computingscheme.

In operation, the input module 944 accepts an operator input, such asprocess setpoint and control selections, and communicates the acceptedinformation or selections to other components for further processing.The database module 946 organizes records, including operatingparameters 954, operator activities 956, and alarms 958, and facilitatesstoring and retrieving of these records to and from a database 952. Anytype of database organization can be utilized, including a flat filesystem, hierarchical database, relational database, or distributeddatabase, such as provided by a database vendor such as OracleCorporation, Redwood Shores, Calif.

The process module 948 generates control variables based on sensorreadings 960 (e.g., sensor readings from a sensor), and the outputmodule 950 generates output signals 962 based on the control variables.For example, the output module 950 can convert the generated controlvariables from the process module 948 into 4-20 mA output signals 962suitable for a direct current voltage modulator. The processor 942optionally can include the display module 951 for displaying, printing,or downloading the sensor readings 960 and output signals 962 viadevices such as the output device 120. A suitable display module 951 canbe a video driver that enables the processor 942 to display the sensorreadings 960 on the output device 120.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise,” “comprising,” and thelike are to be construed in an inclusive sense as opposed to anexclusive or exhaustive sense; that is to say, in a sense of “including,but not limited to.” Words using the singular or plural number alsoinclude the plural or singular number, respectively. When the claims usethe word “or” in reference to a list of two or more items, that wordcovers all of the following interpretations of the word: any of theitems in the list, all of the items in the list, and any combination ofthe items in the list.

U.S. patent application Ser. No. 11/750,953 and U.S. patent applicationSer. No. 13/616,633 are incorporated by reference in their entireties.The various embodiments described above can be combined to providefurther embodiments. All of the U.S. patents, U.S. patent applicationpublications, U.S. patent applications, foreign patents, foreign patentapplications and non-patent publications referred to in thisspecification and/or listed in the Application Data Sheet areincorporated herein by reference, in their entirety. Aspects of theinvention can be modified, if necessary, to employ treatment devices andactuators with a plurality of treatment units, thermally conductivedevices with various configurations, and concepts of the variouspatents, applications, and publications to provide yet furtherembodiments of the invention.

These and other changes can be made to the invention in light of theabove-detailed description. In general, in the following claims, theterms used should not be construed to limit the invention to thespecific embodiments disclosed in the specification and the claims, butshould be construed to include all cooling that operates in accordancewith the claims. Accordingly, the invention is not limited by thedisclosure, but instead its scope is to be determined entirely by thefollowing claims.

I/We claim:
 1. A system for reducing a subject's tissue, comprising: avacuum cup applicator defining a reservoir configured to receive thesubject's tissue under vacuum, the vacuum cup applicator including acurved heat exchanging interface, at least one thermoelectric cooler inthermal contact with the heat exchanging interface, and curved portionswithout any thermoelectric cooler, wherein the curved portions defineopposite sides of the reservoir; an actuator including a pumpfluidically coupled to the vacuum cup applicator; and a processing unitprogrammed to command the pump to operate to draw the subject's tissueinto the reservoir and into thermal contact with the curved heatexchanging interface, command the at least one thermoelectric cooler tocool subcutaneous lipid-rich cells in the tissue held in the reservoirto reduce the subcutaneous lipid-rich cells in the tissue while thesubject's non-lipid-rich cells are not significantly damaged, and afterthe subcutaneous lipid-rich cells are cooled, command the pump to adjusta pressure level in the reservoir to massage the tissue inside thereservoir to cause further reduction of the subcutaneous lipid-richcells in the tissue inside the reservoir.
 2. The system of claim 1,wherein the curved portions have tissue-contacting metal surfacesdefining sections of the reservoir.
 3. The system of claim 1, whereinthe vacuum cup applicator has one or more temperature-controlled metalsurfaces along the reservoir, wherein the at least one thermoelectriccooler is in thermal contact with the one or more temperature-controlledmetal surfaces.
 4. The system of claim 1, wherein the vacuum cupapplicator has a subject-contact surface with a thermal conductivityequal to or greater than 0.05 Watts/Meter-K.
 5. The system of claim 1,wherein the at least one thermoelectric cooler includes a plurality ofthermoelectric coolers spaced apart from one another circumferentiallyabout a sidewall of a tissue-retaining cup of the vacuum cup applicator.6. The system of claim 1, wherein the processing unit is programmed tocommand the pump to operate to adjust the pressure level in thereservoir at a frequency in a range of 0.1 Hz to 10 Hz.
 7. The system ofclaim 1, wherein the vacuum cup applicator includes a tissue-retainingcup and the at least one thermoelectric cooler includes a firstthermoelectric cooler at a first side of the tissue-retaining cup, and asecond thermoelectric cooler at a second side of the tissue-retainingcup opposite the first side, wherein the processing unit is programmedto command the pump to pull a fold of the tissue into the reservoir andagainst the heat exchanging interface.
 8. The system of claim 1, furthercomprising: a sensor positioned to detect the pressure level in thereservoir, and wherein the processing unit is programmed to vary thepressure level inside the reservoir in response to one or more signalsfrom the sensor.
 9. The system of claim 1, wherein the processing unitis programmed to cause the pump to operate to impart oscillatorymechanical energy to a fold of the subject's tissue.
 10. A system forreducing, via cooling, lipid-rich cells of a subject, comprising: avacuum applicator including a cup defining an interior reservoir and atleast one thermoelectric cooler thermally coupled to the cup such that aportion of the cup extends circumferentially along opposite sides of theinterior reservoir and is without any thermoelectric cooler, wherein theat least one thermoelectric cooler is configured to cool a target regionof the subject to reduce the temperature of lipid-rich cells in thetarget region, which is located within the cup, such that the lipid-richcells are substantially affected without substantially affectingnon-lipid-rich cells; an actuator including a pump fluidically coupledto the vacuum applicator, wherein the actuator is configured to impart amassage effect to the lipid-rich cells in the target region when thesubject with the lipid-rich cells in the target region is at leastpartially drawn into the cup; and a processing unit programmed tocommand the actuator such that the pump operates to impart the massageeffect to a cooled the subject's tissue held within the cup.
 11. Thesystem of claim 10, wherein the cup includes curved portions havetissue-contacting metal surfaces defining the interior reservoir. 12.The system of claim 10, wherein the vacuum applicator has one or moretemperature-controlled metal surfaces along the interior portion, andwherein the at least one thermoelectric cooler is in thermal contactwith the one or more temperature-controlled metal surfaces.
 13. Thesystem of claim 10, wherein the vacuum applicator includes one or moresurfaces defining the reservoir, wherein the one or more surfaces have athermal conductivity equal to or greater than 0.05 Watts/Meter K. 14.The system of claim 10, wherein the at least one thermoelectric coolerincludes a plurality of thermoelectric coolers spaced apart from oneanother circumferentially about a sidewall defining the interiorreservoir.
 15. The system of claim 10, further comprising a sensorpositioned to detect a vacuum level in the cup, the processing unit incommunication with the sensor and the pump and programmed to vary thevacuum level between a first vacuum level of at least 2 inches ofmercury and a second vacuum level of at least 5 inches of mercury. 16.The system of claim 10, wherein the processing unit is programmed tocause the pump to operate to adjust a pressure in the interior reservoirto massage the target region.
 17. The system of claim 10, wherein thecup and the pump are configured to keep a fold of the tissue drawn intothe cup while the fold of the tissue is massaged.